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SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.

The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched and modified as described in K033984. No changes to overall implant design or dimensions were made. This submission involved additional studies to support the benefits of the SLActive implant surface.

This is an interesting case where the provided text is a 510(k) summary for a dental implant, which is a medical device. However, 510(k) summaries, especially from 2006, often do not contain detailed information about specific acceptance criteria and the results of studies in the way one might expect for a diagnostic AI device. They primarily focus on demonstrating substantial equivalence to a predicate device.

Based on the provided text, the device in question is the "Straumann Dental Implant System®" with the "SLActive implant surface." The submission focuses on the benefits of this new surface.

Here's an analysis based on the provided text, highlighting the absence of some requested information due to the nature of the 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided 510(k) summary from 2006 does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics in a table format, as one would typically find for a diagnostic AI device aiming for performance targets like sensitivity, specificity, or AUC.

Instead, the "acceptance criteria" can be inferred from the basis for substantial equivalence, which focuses on demonstrating improved performance compared to the existing SLA surface and equivalence to the predicate device in other aspects.

2. Sample Size Used for the Test Set and Data Provenance

The summary states: "The subject device with the modified SLActive surface demonstrates increased osteoblast activity and increased angiogenesis within the first several days after placement when compared to the SLA implant surface in animal studies."

• Sample Size for Test Set: The sample size for the animal studies is not specified in this 510(k) summary.
• Data Provenance (Country of Origin, Retrospective/Prospective): The summary indicates "animal studies." The country of origin and whether the studies were retrospective or prospective are not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and therefore not provided in the 510(k) summary for this type of device. The "ground truth" for an implant's biological performance in animal studies would be derived from histological analysis, biomechanical testing, and other laboratory-based assessments, not typically expert panel consensus on interpretations of images.

4. Adjudication Method for the Test Set

This is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where human readers are assessing diagnostic output. The animal studies described would involve objective measurements and histological analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices that assist human readers. The SLActive implant is a physical medical device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, a standalone performance study as described (for an algorithm) was not done. This concept is also not applicable to a dental implant product. The "standalone" performance here refers to the implant's biological and mechanical performance.

7. The Type of Ground Truth Used

Based on the description of the studies ("increased osteoblast activity and increased angiogenesis... in animal studies," "faster implant secondary stability"), the ground truth would be established through a combination of:

• Pathology/Histology: For observing osteoblast activity and angiogenesis.
• Biomechanical Testing/Measurement of Stability: For assessing implant secondary stability.
• Physiological Outcome Data: Direct measurement of biological responses in animal models.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is a physical implant, not an AI algorithm that requires a training set. The "studies" mentioned are performance evaluations, not algorithm training.

9. How the Ground Truth for the Training Set was Established

• Not applicable/Not provided for the same reasons as point 8.

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